APPLICATION
ANDA078115
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-31
LATEST ACTION
2020-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-02-28Labeling · Supplement 19 · standardAP
2016-11-08Labeling · Supplement 12 · standardAP
2016-11-08Labeling · Supplement 15 · standardAP
2013-06-13Labeling · Supplement 7 · standardAP
2012-01-24Labeling · Supplement 5AP
2010-02-23Labeling · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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